Peelable and flushable ostomy pouch and method of use

ABSTRACT

An ostomy appliance having a face plate assembly and inner and outer pouches joined thereto, has its outer pouch provided with one or more peripherally-extending sealing seams that allow the walls of the outer pouch to be separated by peeling forces applied in directions transverse to such seam or seams. In preferred embodiments, the sealing seam, also peelably join the peripheral edges of the outer pouch to those of the inner pouch. A method of disposing of the pouch assembly of such an ostomy appliance is also disclosed.

RELATED APPLICATIONS

This is a Divisional of U.S. patent application Ser. No. 10/969,523,which claims the benefit of the filing date of U.S. Provisional PatentApplication Ser. No. 60/512,760, filed Oct. 21, 2003 and claims priorityto Danish Patent Application Serial No. 2003/01549, filed Oct. 21, 2003.

BACKGROUND AND SUMMARY

The present invention relates to an ostomy appliance for receivingdischarge from a human stoma and comprising:

-   -   attachment means for attaching the appliance to the peristomal        skin surface of a user of the appliance, and    -   an ostomy pouch assembly comprising:    -   an inner pouch attached to said attachment means and having a        first aperture for receiving the stoma of said user,    -   said inner pouch being defined by a flexible body side or        proximal inner pouch wall and a flexible distal inner pouch        wall, and one or more peripherally extending inner pouch sealing        seams,    -   an outer pouch enclosing said inner pouch, attached to said        attachment means and having a second aperture for receiving said        stoma and being aligned with said first aperture,    -   said outer pouch being defined by a flexible body side or        proximal outer pouch wall and a flexible distal outer pouch        wall, and one or more peripherally extending outer pouch sealing        seams.

In connection with the disposal of the pouch assembly or the entireostomy appliance after use thereof when the inner pouch is more or lessfull of stomal discharge, it is important that this can be done in amanner that is convenient for the user of the appliance. This entailsthat it should not be necessary to carry the full inner pouch to adisposal site outside the premises in which the full pouch is to beexchanged with a new, empty pouch. The best solution to this disposalproblem is to flush the inner pouch out through a toilet.

Many solutions to this problem have been suggested, for instance in EP 0703 762, EP 0 611 123, U.S. Pat. No. 4,372,308, GB 2227668, WO 0182846,EP 0 703 762, U.S. Pat. No. 5,938,647, U.S. Pat. No. 5,769,831 and U.S.Pat. No. 5,455,091, the disclosure of which is hereby incorporatedherein by reference.

A fully satisfactory solution has not yet been obtained where the innerpouch can easily flow through the sewage system and not cause cloggingand overloading of the sewage treatment facilities, where the separationof the inner pouch from the rest of the appliance can be achieved in aneasy and secure manner and where the rest of the pouch assembly can bedisposed of in a convenient and hygienic manner.

It is a main object of the invention to provide an ostomy appliancewhere the above listed requirements have been met to a higher degreethan before.

According to the invention, this object is achieved by said one or moreouter pouch sealing seams being manually peelable such that theattachment forces provided by said one or more peelable outer pouchsealing seams may be manually eliminated by manually pulling said outerpouch wall in a direction transverse to said one or more peelable outerpouch sealing seams.

Hereby, separation forces are applied to said one or more peelable outerpouch sealing seams in a direction transverse thereto so as to peel saidouter pouch wall away from the rest of the pouch assembly whereby theinner pouch can be exposed in a simple and convenient manner that doesnot require any special dexterity.

In the currently preferred embodiment of an ostomy appliance accordingto the invention, said one or more outer pouch sealing seams peelablyattach said distal outer pouch wall to said distal inner pouch wall andsaid proximal outer pouch wall to said proximal inner pouch wall.

Hereby a particularly simple embodiment is achieved, where the innerpouch sealing seam and the outer pouch sealing seams may be carried outin one single sealing operation.

Alternatively, said one or more outer pouch sealing seams may peelablyattach said distal outer pouch wall directly to said proximal outerpouch wall.

Furthermore said one or more outer pouch sealing seams may peelablyattach said distal outer pouch wall partly to said proximal outer pouchwall and partly to said distal inner pouch wall and peelably attach saidproximal outer pouch wall to said distal outer pouch wall and partly tosaid proximal inner pouch wall.

In said currently preferred embodiment, the inner pouch is attached tosaid attachment means by a peelable interior sealing seam extendingaround said stoma receiving aperture in said inner pouch. Hereby, theinner pouch can be detached from the attachment means in a simple andconvenient manner that does not require any special dexterity.

In said currently preferred embodiment, the material of said inner pouchwalls is biodegradable. Hereby, the load on the sewage treatment plantsis reduced.

In said currently preferred embodiment said inner pouch walls are madeof a plastic film laminated to a web of a non-woven fibrous materialsuch as paper, preferably a paper of a toilet tissue type, said webfacing outwards relative to the interior of said inner pouch.

Hereby, a particularly efficient and simple manner of obtaining apeelable sealing seam between the inner pouch walls and the outer pouchwalls is obtained, and tissue paper readily disintegrates in water sothat when discarded into a flush toilet, the fibers of the paper, whichare preferably cellulosic and biodegradable, although not soluble inwater, quickly disperse.

Furthermore, the use of paper as the outer layer of the inner pouchlaminated walls affords important advantages regarding the dry strengthof the inner pouch, the soft feel and appearance of the inner pouch andthe disposability of the inner pouch by being flushed through a toilet.

Paper in dry condition has a relatively large tensile strength, and thuslaminating paper on to a film of plastic material allows using a thinnerfilm for achieving liquid and gas impermeability as well as sufficientcombined strength. This is advantageous from an economic viewpoint, asless relatively expensive plastic material is required for the innerpouch walls. However, the main advantage is that the relatively thinfilm when deprived of the dry strength of the paper after beingsubmerged in water is prone to being broken up into more easily degradedfragments such that the effect on the sewage treatment systems isgreatly reduced.

In said currently preferred embodiment. said non-woven material and/orsaid plastic film are biodegradable.

In said currently preferred embodiment. said inner pouch walls areimpermeable to liquid and gas and permeable to odors, and said outerpouch walls are impermeable to liquid, gas and odors. This allows theuse of a very thin liquid and gas barrier for the inner pouch wallswhich is of particular importance for the environmental impact thereof.

Preferably, said one or more outer pouch peeling seams comprises apeeling action initiation zone, where said one or more outer pouchsealing seams comprises a peak-like extent tapering in the directionopposite a predetermined peeling direction. Hereby, the area of thepeeling seam where the peeling action is to be initiated is reducedthereby facilitating the peeling operation.

Preferably, said one or more outer pouch peeling seems comprises apeeling action ending zone, where said one or more outer pouch sealingseams comprises a peak-like extent tapering in a predetermined peelingdirection. Hereby, the area of the peeling seam where the peeling actionis to be ended is reduced thereby facilitating the peeling operation.

Preferably, said interior inner pouch sealing seam comprises a peelingaction initiation zone, where interior inner pouch sealing seamcomprises a peak-like extent tapering in the direction opposite apredetermined peeling direction, and said interior inner pouch sealingseam comprises a peeling action ending zone, where interior inner pouchsealing seam comprises a peak-like extent tapering in a predeterminedpeeling direction.

In said currently preferred embodiment, said proximal outer pouch wallis attached to said attachment means by a heat sealed sealing seam.Hereby at least part of the attachment means can be disposed of togetherwith the outer pouch walls.

Alternatively, said proximal outer pouch wall is attached to saidattachment means by a peelable sealing seam. Hereby, the attachmentmeans may be disposed of separate from the outer pouch walls.

In one embodiment of a so-called two-piece ostomy appliance according tothe invention, said attachment means comprise a face plate assemblycomprising a wafer of skin friendly adhesive material having a thirdaperture for receiving said stoma aligned with said first and secondapertures, and a first coupling ring surrounding said third aperture andattached to said wafer and in engagement with a second coupling ringsurrounding said first and second apertures and attached to saidproximal outer pouch wall and to said proximal inner pouch wall.

In a currently preferred embodiment of a two-piece ostomy applianceaccording to the invention, said proximal outer pouch wall is attachedto said second coupling ring by means of a heat sealed sealing seam.Hereby, the second coupling ring is fixedly attached to the outer pouchwall for disposal therewith.

Advantageously, said proximal inner pouch wall is attached to saidsecond coupling ring by means of said peelable interior sealing seam.Hereby, the inner pouch may be disposed of separately from the secondcoupling ring.

In said currently preferred embodiment, said proximal inner pouch wallis attached to said proximal outer pouch wall in a region surroundingsaid first and second apertures by means of said peelable interiorsealing seam. Hereby, the inner pouch may be manually separated from theouter pouch in a simple and convenient manner.

In a second embodiment of a two-piece ostomy appliance according to theinvention, said attachment means comprise a face plate assemblycomprising a wafer of skin friendly adhesive material having a thirdaperture for receiving said stoma aligned with said first and secondapertures, and a first coupling means surrounding said third apertureand attached to said wafer and in releasably adhesive engagement with asecond coupling means surrounding said first and second apertures andattached to said proximal outer pouch wall and/or to said proximal innerpouch wall.

The proximal outer pouch wall may attached to said second coupling meansby means of a heat sealed sealing seam, and said proximal inner pouchwall may be attached to said second coupling means by means of saidpeelable interior sealing seam, or said proximal inner pouch wall may beattached to said proximal outer pouch wall in a region surrounding saidfirst and second apertures by means of said peelable interior sealingseam.

In a so-called one-piece ostomy appliance according to the invention,said attachment means comprise a face plate assembly comprising a waferof skin friendly adhesive material having a fourth aperture forreceiving said stoma aligned with said first and second apertures, and acarrier sheet attached to the distal surface of said wafer and attachedto said proximal outer pouch wall and to said proximal inner pouch wall.

In a currently preferred embodiment, of a one-piece ostomy applianceaccording to the invention, said proximal outer pouch wall is attachedto said carrier sheet by means of a heat sealed sealing seam.

Advantageously, said proximal inner pouch wall is attached to saidcarrier sheet by means of said interior peelable sealing seam.

In said currently preferred embodiment, said proximal inner pouch wallis attached to said proximal outer pouch wall in a region surroundingsaid first and second apertures by means of said peelable interiorsealing seam.

In said currently preferred embodiment, said peelable interior sealingseam is constituted by a sheet of film or textile with a fifth stomareceiving aperture and having adhesive on both opposed surfaces. Thisaffords a particularly secure peelable adhesion between the inner pouchand the rest of the appliance.

Advantageously, an annular insert having a sixth aperture for receivingsaid stoma is provided within said second coupling ring for preventingsaid stomal discharge from soiling said second coupling ring. Hereby,the second coupling ring can be disposed of in a hygienic manner becauseit is not soiled by the stomal discharge.

The attachment forces provided by said one or more peelable outer pouchsealing seams are preferably such that the pulling force required formanually eliminating said attachment forces is between approx. 0.5Newton and approx. 6 Newton, preferably between approx. 0.7 Newton andapprox. 5.5 Newton, even more preferably between approx. 0.8 Newton andapprox. 5.0 Newton, even more preferably between approx. 0.9 Newton andapprox. 4.5 Newton and most preferably between approx. 1.0 Newton andapprox. 4.0 Newton.

Hereby the pulling or peeling force is such that the risk of unintendedripping of the outer pouch walls and especially the inner pouch walls isminimal during peeling of the outer pouch sealing seams while theattachment forces are sufficient to ensure the integrity of the pouchassembly during use thereof. In said currently preferred embodiment,said outer pouch peelable sealing seams are between 4 and 6 mm wide,preferably approximately 5 mm wide. It has turned out that this affordsthe best balancing of easy peelability and secure fastening of the pouchwalls to one another during use of the pouch assembly.

In said currently preferred embodiment, at least a portion the outerperipheral edges of said outer pouch walls and inner pouch walls hasbeen formed by cutting through said walls in the areas of said outerpouch peelable seams. The cutting friction creates a melting zone at theedge of the outer and inner pouches that prevents wicking of water froma shower or bath into the peelable sealing seams containing a fibrousmaterial between the inner pouch walls and the outer pouch walls.

In said currently preferred embodiment, a portion of said outer pouchwalls and inner pouch walls extend beyond said outer pouch peelableseams to form inner pouch wall and outer pouch wall gripping tabs forpeeling said walls apart. Hereby, a particularly simple and easilyimplemented peeling function is obtained.

In said currently preferred embodiment, said outer pouch peelable seamsare made by applying heat and/or RF to the outer surface of one or bothof said outer pouch walls.

In said currently preferred embodiment, an area of each of said innerpouch wall gripping tabs extending into the area covered by the adjacentouter pouch peelable seam has been subjected to application of heatand/or RF prior to the formation of said outer pouch peelable seams.Hereby wicking of water from a shower or a bath is prevented in theregion of the tabs into the peelable seams containing a fibrous materialbetween the inner pouch walls and the outer pouch walls.

In said currently preferred embodiment, the fibers of said paper have agenerally uniform orientation and said orientation is transversal to aline extending from the top to the bottom of said outer and innerpouches when a user to which said pouches have been applied around astoma is standing erect, said orientation preferably being generallyorthogonal to said line. Hereby, a particularly neat and uniform peelingis obtained where most of the paper remains attached to the inner pouchwalls after peeling.

In another aspect, the present invention relates to an ostomy pouchassembly for use in an ostomy appliance according to the invention.

In a further aspect, the present invention relates to an inner pouch foruse in an ostomy appliance according to the invention.

In a yet further aspect, the present invention relates to a method ofdisposing of an ostomy pouch assembly of an ostomy appliance asspecified above after use thereof, said method comprising the steps of:

-   -   gripping an edge portion of said distal outer pouch wall,    -   pulling said edge portion of said distal pouch wall away from        the body of the user such that the attachment of said distal        outer pouch wall by the respective one of said one or more        peelable outer pouch sealing seams to the rest of said appliance        is disrupted,    -   gripping mutually superimposed edge portions of said distal and        proximal inner pouch wall,    -   pulling said superimposed edge portions away from the body of        the user such that the attachment of said inner pouch by the        respective peelable sealing seams to the rest of said appliance        is eliminated, and    -   disposing of the inner pouch with contents in a toilet bowl.

In a final aspect, the present invention relates to the use of aflexible composite film made of a plastic film laminated to a web of anon-woven fibrous material such as paper, preferably a paper of a toilettissue type, for providing a peelable sealing seam between an innerpouch and an outer pouch of an ostomy appliance, said inner pouch beingsurrounded and enclosed by said outer pouch, and the walls of said innerpouch being made of said composite film with said web facing outwardsrelative to the interior of said inner film.

In the following, the invention will be explained more in detail withreference to various embodiments of the invention shown, solely by wayof example, in the drawings.

DRAWINGS

FIG. 1 is a schematic plan view, seen from the body side, of a firstembodiment of a two-piece ostomy pouch according to the invention,

FIG. 2 is a diagrammatic cross sectional view taken along line A-A inFIG. 1 with the film thicknesses exaggerated for illustrative purposes,

FIG. 3 is an enlarged scale view of the top portion of FIG. 2,

FIG. 4 is a cross sectional view corresponding to FIG. 3 of a secondembodiment of the ostomy appliance according to the invention,

FIG. 5 is an enlarged scale view of the area encircled in FIG. 4,

FIG. 6 is a view corresponding to FIG. 4 of a modification of theembodiment of FIGS. 4-5,

FIG. 7 is a view corresponding to FIG. 4 of a further embodiment of atwo-piece ostomy appliance according to the invention,

FIG. 8 is a schematic plan view, seen from the body side, of a firstembodiment of a one-piece ostomy pouch according to the invention,

FIG. 9 is a diagrammatic broken away, cross sectional view of the topportion of the appliance of FIG. 8 taken along line B-B in FIG. 8 withthe film thicknesses exaggerated for illustrative purposes,

FIG. 10 is a view corresponding to FIG. 8 of a second embodiment of aone-piece ostomy pouch according to the invention.

FIG. 11 is a view corresponding to FIG. 4 of a further embodiment of atwo-piece ostomy appliance according to the invention,

FIG. 12 is a view corresponding to FIG. 4 of a yet further embodiment ofa two-piece ostomy appliance according to the invention,

FIG. 13 is a schematic frontal view seen in the direction towards thebody of the user of an ostomy appliance according to the inventionillustrating the peeling off of the distal outer pouch wall,

FIG. 14 is a view similar to FIG. 13 illustrating the peeling off of theinner pouch,

FIG. 15 is a schematic plan view, seen from the distal side, of thecurrently preferred embodiment of a two-piece ostomy pouch according tothe invention, and

FIG. 16 is a diagrammatic cross sectional enlarged scale view takenalong line C-C in FIG. 15 with the film thicknesses exaggerated forillustrative purposes.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to FIGS. 1-3, an ostomy appliance referenced generally bythe numeral 1 comprises an outer pouch 2 comprised of a body side orproximal wall 2 a and an opposed distal wall 2 b. The appliancefurthermore comprises an inner pouch 3 comprised of a proximal wall 3 aand a distal wall 3 b. The outer pouch walls 2 a and 2 b are covered bya comfort layer 4 of +a non-woven material.

The walls 2 a and 2 b are made of a flexible plastic film that isimpermeable to liquids, gasses and odors. The walls 3 a and 3 b are madeof a flexible plastic film that is impermeable to liquids and gasses andpermeable to odors.

The inner pouch 3 is formed by sealingly securing the two inner walls 3a and 3 b to each other along the peripheries thereof by means of aninner pouch seam 5 either being a heat sealing seam or an adhesive seam.

The outer pouch 2 is formed by sealing the proximal and distal outerpouch walls 2 a and 2 b, respectively, to the inner pouch proximal anddistal walls 3 a and 3 b, respectively by means of peelable sealingseams 6 and 7, respectively, extending along the outer periphery of theouter and inner pouch walls.

The comfort layers 4, which are optional, are sealed to the outer pouchwalls 2 a and 2 b by means of heat sealing or adhesive seams 8 and 9,respectively, extending along the outer periphery of the outer pouchwalls.

Both the inner pouch 3 and the outer pouch 2 have a stoma receivingaperture 10 and 11, respectively in the proximal walls 3 a and 2 a,respectively.

The appliance 1 further comprises a pouch coupling ring 12 secured tothe proximal outer pouch wall 2 a by means of a circumferential heatseal 13 or other suitable means. The area surrounding the aperture 10 ofthe proximal inner pouch wall 3 a is attached to the corresponding areaof the proximal outer pouch wall 2 a by means of an annular peelableseam 14.

The appliance 1 further comprises a face plate assembly 15 having anadhesive layer 16 for adhering the face plate assembly to the peristomalsurface of a user of the appliance 1 after having removed a releasesheet 17 covering the proximal or body side surface of the adhesivelayer 16. The adhesive layer is provided with a stoma receiving aperture16 a.

A carrier sheet 18 is attached to the distal surface of the adhesivelayer 16, and a face plate coupling ring 19 is secured to the carriersheet 18, such that interconnection of the two coupling rings 12 and 19as shown in FIG. 2 will allow the pouch assembly 2, 3 to be adhered tothe peristomal skin surface of a user with the stoma inserted in theapertures 16 a, 10 and 11 such that stomal discharge may enter the innerpouch 3. The face plate coupling ring 19 is provided with two optionalbelt loops 15 a and an optional burp tab 15 b.

The inner and outer walls 2 a, 2 b, 3 a, 3 b as well as the comfortlayers 4 project outwardly and upwardly are prolonged at the top of theappliance to form a tongue or projection 20 for providing non-connectedand separable gripping tabs 20 a-20 f for the separation of the twopouches for disposal thereof as explained below in connection with FIGS.13 and 14.

In use, when the inner pouch is full of stomal discharge and the pouchneeds to be replaced by an empty pouch, the user or a helper (see FIGS.3 and 13) grips the tabs 20 a and 20 b together with one hand 40 and therest of the tabs with the other hand 41 and pulls the tabs 20 a and 20 baway from the body and downwardly. Hereby the connection between theouter pouch wall 2 b and the inner pouch wall 3 b by means of thepeelable sealing seam 7 is broken or disrupted such that the proximalouter pouch wall 2 b with its comfort layer 4 is peeled away from theappliance 1.

Thereafter, the user (see FIGS. 3 and 14) grips the tabs 20 c and 20 dtogether with one hand 40 and the tabs 20 e and 20 f with the other hand41 and pulls the tabs 20 c and 20 d outwardly and downwardly whereby thepeelable sealing seam 6 gives way so that the inner pouch 3 is peeledaway from the outer pouch proximal wall 2 a until the level of the toppoint of the peelable sealing seam 14 is reached. This peelable seam 14also gives way to the pulling force exerted on the tabs 20 c and 20 d sothat finally the entire inner pouch 3 with its content of stomaldischarge has been peeled away from the proximal outer pouch wall 2 a.The stoma 42 of the user is now exposed (see FIG. 14).

Now the inner pouch 3 with contents can be deposited in the bowl of atoilet and flushed away while the proximal outer pouch wall 2 a withcomfort layer 4 and coupling ring 13 can be removed from the face plateassembly 15. The outer pouch walls 2 a and 2 b with correspondingcomfort layers 4 and the coupling ring can now be folded together and bedisposed of in some other manner, for instance in a pocket, a hand bagor a refuse container.

The material of the inner and outer pouch walls may be a film of anysuitable plastic material. The outer pouch wall film material isimpermeable to liquids, gasses, while the inner pouch wall film isimpermeable to liquids and gasses, but not necessarily to odors. Byallowing the inner pouch wall film to be permeable to odors, the filmmay be made thinner and thus be more easily disintegrated andbiodegraded.

It is preferable that the inner pouch wall film material bebiodegradable so that the sewage treatment facilities are notinconvenienced to an unnecessary degree. By allowing the inner pouchwall film to be permeable to odors, the film may be made thinner andthus be more easily disintegrated and biodegraded.

Examples of biodegradable films suitable for the inner pouch walls 3 aand 3 b are biodegradable aliphatic polyesters such aspolycaptrolactone.

A biodegradable and liquid impermeable material that currently isconsidered suitable for the inner pouch wall film are biodegradablealiphatic polyesters such as polycaprolactone (for instance TONE Polymersupplied by Dow Chemical Company) or a biodegradable aliphatic-aromaticcopolyester (for instance ECOFLEX supplied by BASF).

The peelable sealing seams 6, 7 and 14 may be provided in various ways,for instance by utilizing a peel lacquer or varnish which gives apeelable adhesion to either the inner or the outer pouch walls or toboth walls. The type of peelable lacquer or varnish depends on thematerial chosen for the pouch bag films.

Peel lacquers that currently are considered to be suitable for certainfilm materials are “Appeel” resins from the company duPont, and hot meltpeelable adhesives supplied under the trade names Dispomelt 34-2881,34-5519, Instaweld 34-3306 and Bondmaster 34-3306 by the companiesNational Starch Adhesive and Chemical Corporation.

Another way of implementing the peelable sealing seams is to use anintermediate film of polybutylene or an intermediate three-layer filmsupplied by the company Rexam under the trade name Core-Seal, thepeeling occurring between the two outer films and the internal film orlayer, the external films being securely heat sealed to the inner andouter pouch wall films.

A further way of implementing the peelable seams is to use a siliconerelease film such as the type used for labels.

In the context of the present invention, the term peelable utilised inthe specification and claims is to be understood to mean that theconnection between two films, be it by means of an adhesive, heatsealing or other means, can be broken, disrupted or eliminated bymanually urging one film away from the other without compromising theintegrity of the films.

A currently preferred manner of providing peelable sealing seams willnow be described with reference to FIGS. 4-5. The embodiment of FIGS.4-5 is identical to the embodiment of FIGS. 1-3 except for the innerpouch bag walls 21 a and 21 b that are made of a heat sealable, liquidand gas impermeable, odor permeable film of plastic material laminatedto a web of paper.

The paper sheet (indicated by cross hatches) is located on the outersurface of the inner pouch walls 21 a and 21 b facing the outer pouchwalls 2 a and 2 b, respectively.

The peelable sealing seams 22, 23 and 24 between the inner pouch walls21 a, 21 b and the outer pouch walls 2 a, 2 b, respectively are providedby heat sealing whereby the plastic material of the outer pouch walls 2a and 2 b melts and flows into the interstices of the paper sheet suchthat a bond is created between the films 2 a and 2 b and the papersheet.

However, as the plastic material does not flow all the way through thepaper sheet to fuse with the plastic material of the inner pouch walls 3a and 3 b, respectively, the strength of the bond created by the heatsealing is dependent on the internal adherence forces between the fibersof the paper sheet and/or between the fibers and the films 2 a, 2 b and3 a, 3 b.

By applying a peeling force transversely to the surface of the papersheet, the bond can be broken manually so that the walls 2 a and 3 a and2 b and 3 b can be separated by the manual peeling action describedabove for separating the outer pouch walls from the inner pouch fortoilet disposal of the latter.

Alternatively, the outer pouch walls may be peelably adhered to thepaper sheet by means of an adhesive having greater adhesion strengththan the inner cohesion of the paper fibers. Finally, it is conceivablethat the peelability of the seams be obtained by a relatively weakadhesion between, on the one hand, the outer pouch walls and/or theinner pouch walls and, on the other hand, the paper sheet so that theinner cohesion of the paper fibers is of less importance.

When peeling the peelable seams 8 and 9, the peeling force necessary fordisrupting the peelable sealing seams will vary along the seamsaccording to the width of the seam peeling front, i.e. the width of theseam in the direction at right angles to the peeling direction. Thus,the necessary peeling force will be largest when the peeling front islocated at the top and bottom of the sealing seams 8 and 9 in forinstance FIG. 8 and the necessary peeling force will be smallest whenthe peeling front of the seams 8 and 9 is located along the sides of thepouch.

The necessary peeling force should be such that the peeling force caneasily be exerted by the user of the appliance without risk of rippingthe outer pouch walls 2 a and 2 b and especially the inner pouch walls 3a and 3 b when peeling. However, the necessary peeling force should alsoreflect attachment forces in the peelable seams 8 and 9 sufficient forensuring the integrity of the appliance during use thereof.

It is currently believed that the necessary peeling force should be inthe range of between approx. 0.5 Newton and approx. 6 Newton, preferablybetween approx. 0.7 Newton and approx. 5.5 Newton, even more preferablybetween approx. 0.8 Newton and approx. 5.0 Newton, even more preferablybetween approx. 0.9 Newton and approx. 4.5 Newton and most preferablybetween approx. 1.0 Newton and approx. 4.0 Newton.

The use of paper as the outer layer of the inner pouch double-layeredwalls affords further important advantages regarding the strength of theinner pouch, the feel and appearance of the inner pouch and thedisposability of the inner pouch by being flushed through a toilet.

Water-disintegratable paper in dry condition has a relatively largetensile strength, and thus laminating paper on to a film of plasticmaterial allows using a thinner film for achieving liquid and gasimpermeability as well as sufficient combined strength.

This is advantageous from an economic viewpoint as less relativelyexpensive plastic material is required for the inner pouch walls.

Furthermore, when paper becomes wet, it loses some of its cohesion andtensile strength, and therefore the disposability of the inner pouch ina toilet is enhanced, as the decomposition of the inner pouch isfacilitated because, firstly, the film is thinner and, secondly, becauseplastic material, even though it is a biodegradable plastic material, isrelatively slow to disintegrate and biodegrade.

Finally, the user will be more comfortable throwing something feelingand looking like a paper or toilet tissue bag into the toilet thanthrowing a plastic bag into the toilet.

Paper types currently considered to be suitable for use in the innerpouch wall laminate are 100% cellulosic tissue paper of low wet strengthsuch as Little Rapids Corp-Shawano Specialty Papers cellulose basedpaper Grade 3040 supplied by LRC-Shawano Specialty Papers, USA or paperincluding a binder such as Superseal Teabag Paper grade 478401 suppliedby J.R. Crompton Ltd, UK.

In the context of the present invention, the term paper utilised in thespecification and claims is to be understood to mean a non-woven fibrousweb containing a substantial amount of cellulose fibers, preferably morethan 30% by weight, more preferably more than 50% by weight, even morepreferably more than 60% by weight and even more preferably more than70% by weight, most preferably more than 95% by weight, and preferablywithout a binder for reasons of biodegradability.

Referring now to FIG. 6, the embodiment shown therein is identical tothe embodiment of FIGS. 4-5 except for an additional peripheral heatsealing seam 25 of the inner pouch walls 21 a and 21 b to each other.

The purpose of this additional seam 25 is to safeguard against leakageof stomal discharge from the inner pouch if the peeling of the proximalouter pouch wall 2 b from the distal inner pouch wall 21 b or thepeeling of the proximal inner pouch wall 21 a from the proximal outerpouch wall 2 a results in ripping of one or both of the inner pouchwalls because of too forceful peeling or other reasons. The heat sealingseam 25 is shown spaced from the heat sealing seam 5, but they may becontiguous.

Referring now to FIG. 7, the embodiment shown therein is identical tothe embodiment of FIGS. 1-3 except that the peelable sealing seam 26corresponding to sealing seam 14 in FIGS. 1-3 is an annular film ortextile with adhesive on both surfaces so that it adheres to both theinner pouch wall 3 a and the outer pouch wall 2 a, and that an annularinsert 27 of cardboard is arranged as a tight fit against the innersurface 12 a of the coupling ring 12.

The function of the annular insert 27 is to protect the inner surface 12a of the coupling ring 12 from contact with stomal discharge such thatwhen disposing of the inner pouch in a toilet, the insert can be removed(for instance by being pressed out manually) and discarded in the toiletsuch that no part of the outer pouch and coupling ring is soiled by thestomal discharge and thus can be carried away in a pocket with no riskof bad odors and soiling of the pocket.

Protection of the inner surface of the coupling ring against beingsoiled by stomal discharge may also be achieved by peelably adhering anoutwardly extending collar portion of the inner pouch wall 3 a adjacentthe coupling ring to said inner surface such that the collar will servethe same purpose as the insert 27, and upon removal of the inner pouchfrom the coupling ring will leave the coupling ring free of stomaldischarge.

The releasable attachment of the pouch assembly comprising the innerpouch 3 and outer pouch 2 to the adhesive face plate assembly by meansof the coupling rings 12 and 19 may be substituted by a releasableadhesive attachment of the outer pouch 2 and/or the inner pouch 3 to thecarrier sheet 18 either directly or by means of releasable adhesionbetween an intermediate element attached to the carrier sheet 18 and/orthe outer pouch 2 and/or the inner pouch 3 such that a new pouchassembly 2, 3 may be adhered to the face plate assembly 15 after removaland disposal of the previous pouch assembly.

Referring now to FIGS. 8-9, a one-piece ostomy appliance is shown,wherein the proximal outer pouch wall 2 a is heat sealed to the carriersheet 18 by means of an annular heat sealing seam 28 while the proximalinner pouch wall 3 a is peelably sealed to the outer pouch wall 2 aaround the stoma receiving aperture by means of a peelable sealing seam29 constituted by an annular film or textile with adhesive on both ofits opposed surfaces.

At the top of the pouch the tongue 20 of the embodiment of FIGS. 1-3 hasbeen substituted by three tongues 30, 31 and 32. The tongues arestaggered and marked with the numerals 1, 2 and 3 to indicate the orderin which they are to be gripped and pulled away, the tongue 32 beinggripped first by one hand while gripping the tongue 31 with the otherhand and pulling the tongue 32 away from the body of the user and so onuntil the desired separation of the appliance into two outer bag wallsand the inner pouch has been accomplished.

Referring now to FIG. 10, this embodiment of a one-piece ostomyappliance according to the invention is very similar to the embodimentof FIGS. 8-9, but is provided with a lemon-like contour of the sealingseams 5, 6, 7, 8 and 9.

The object of this pointed contour is to facilitate the peelingseparation of the peelable sealing seams 6 and 7 between the outer pouchwalls 2 a and 2 b and the inner pouch walls 3 a and 3 b, respectively.

The pointed ends 33 and 34 act to concentrate the peeling forces andthus render it easier to initiate and end the peeling operation,respectively by presenting a small attachment area to start and end thepeeling action.

The peelable sealing seam 35 between the inner pouch proximal wall andthe outer pouch proximal wall around the stoma receiving apertures inthese walls can either be round or have pointed ends 36 and 37 forfacilitating the initiation and ending of the peeling operation onpeelable sealing seam 35.

Referring now to FIG. 11, this embodiment is very similar to theembodiment of FIG. 4 except that the outer pouch film walls 2 a and 2 band the comfort layers 4 have been extended beyond the periphery of theinner pouch walls 21 a and 21 b and an additional peelable sealing seam38 has been provided for peelably joining the outer pouch walls togetheras a safety measure in case odors or flatus gasses wick through thefibers of the paper web laminated to the inner pouch film wall. In suchcase the additional sealing seam 38 will prevent the gasses and odorsfrom exiting the outer pouch. Furthermore, this extra seam 38 willsafeguard against water (for instance during showering) penetrating thefibers of the paper layer and reducing the sealing strength of thepeelable sealing seems 22 and 23.

Referring now to FIG. 12, this embodiment is identical to the embodimentof FIG. 11 except that the peelable sealing seams 22 and 23 between thefilm walls 2 a and 21 a and 2 b and 21 b, respectively as well as thesealing seams 8 and 9 between the comfort layers and the film walls 2 aand 2 b, respectively, have been left out so that the inner pouch isonly connected to the outer pouch by the peelable sealing seam 24 aroundthe stoma receiving apertures. However, a peelable seal remains betweenthe peripheral edges of the outer pouch walls 2 a and 2 b to allow suchwalls to be peeled apart and expose the inner pouch 3.

This embodiment has the same advantages as the FIG. 11 embodiment plusthe advantage that the inner pouch 3 can be separated from the outerpouch 2 more easily and with less risk of rupturing the inner pouchduring the separation.

Referring now to FIGS. 15 and 16, this currently preferred embodiment issimilar to the embodiment shown in FIGS. 4-5. The inner and outerpouches 3 and 2 are symmetrical about a vertical axis of symmetry.

The paper sheet or any other suitable fibrous layer adhered or laminatedto the outer surfaces of the inner pouch walls 3 a and 3 b may wickwater present at the peripheral edge of the pouches 2 and 3, forinstance when the user of the pouch assembly is bathing or showering,into the peelable seals 22 and 23 whereby the sealing strength thereofmay be reduced to an extent that the seals 22 and 23 fail whereby theouter pouch walls 2 a and 2 b may become unintentionally separated fromthe inner pouch walls 3 a and 3 b.

To prevent this wicking from taking place, the outermost portion of theperipheral sealing seams 5, 8, 9, 22 and 23 is cut away along line 49such that the heat generated by the cutting action melts and fuses theplastic material of outer and inner pouch walls 2 a, 2 b and 3 a, 3 b tocreate a seal along line 49 preventing water from coming into contactwith the fibrous layers on the outer surfaces of the inner pouch walls 3a and 3 b and thus preventing the wicking of water into the peelableseals 22 and 23.

The distal cover sheet 4 and the distal outer pouch wall 2 b are cutaway along cut lines 50 to expose a region 51 b of the upper tab portionof the distal inner pouch wall 3 b such that when initiating the peelingoff of the outer pouch wall 2 b with corresponding cover sheet 4, theuser of the pouch assembly or a caregiver can grip the inner pouch tabsprojecting above the cut lines 50 with one hand and grip the shortenedtab portions below the cut lines 50 with the other hand and peeldownwards in a manner very similar to the manner illustrated in FIG. 13.

So as to avoid wicking of water into the peelable seals 22 and 23through the fibrous material attached to the outer surfaces of the tabportions 20 c and 20 d of the inner pouch walls 3 b and 3 a,respectively, heat is applied to areas 51 a and 51 b of the tab portions20 d and 20 c, respectively, delimited by the peripheral edge of the tabportions and the dotted lines 52 a and 52 b, respectively, so as to meltthe film material of the inner pouch walls in these areas so that thefilm material penetrates between the fibers of the fibrous materialthereby reducing the wicking ability of the fibrous material.

As the areas 51 b and 51 a of the inner pouch tabs extend into the areaof the peelable seams 22 and 23 thereby forming the areas 53 a and 53 bdefined by the dotted lines 52 a and 52 b, these areas 53 a and 53 b aresubjected to the heat sealing applied to form the peelable seals 22 and23 whereby the wicking ability of the fibrous material is completelyeliminated in the areas 53 a and 53 b because of further melting of theinner pouch wall film and melting of the outer pouch wall film wherebythe interstices between the fibers in the fibrous material aresubstantially blocked and consequently no wicking path can beestablished for water inflow into the peelable seals 22 and 23.

It has turned out that for obtaining the best peel results the width ofthe peelable seals 22 and 23 should be between 4 and 6 mm, preferablyapproximately 5 mm, and that the width of the region in which heat andpressure is applied to form the peelable seal should be about 2 mmlarger so that approx. 2 mm of the initial width of the peelable seals22 and 23 is removed by the anti wicking cut along line 49.

Because of the symmetrical shape of the inner and outer pouches, thepeeling action to peel off the distal outer pouch wall and the innerpouch takes place substantially parallel to the axis of symmetry and hasturned out to require the least dexterity and force application to carryout the peeling action.

If the fibrous material attached to the outer surfaces of the innerpouch walls 3 a and 3 b is paper with a certain orientation of thecellulosic fibers, it has turned out that the orientation of thecellulosic fibers should be transverse to the peeling direction, i.e. inthe case of the embodiment in FIGS. 15 and 16, transverse to the axis ofsymmetry, preferably substantially orthogonal to said axis. Hereby thebest peeling result is obtained where most of the paper layer remainsattached to the inner pouch walls after peeling of the peelable seams 22and 23 has taken place.

All the features discussed in connection with the two-piece embodimentsmay be applied to the one-piece embodiments, and vice versa.

Furthermore, the insert 27 of FIG. 7, the triple tongues 30-32 of FIGS.9 and 10, the paper/film laminate of the inner pouch walls of FIGS. 2,5, 11 and 12, the double adhesive annular film 26 of FIGS. 7 and 9, thecontours with pointed ends 33 and 34 and 36 and 37 of the sealing seams6, 7 and 35, respectively, and the anti-wicking measures, the peelingseam width and the paper fiber orientation of FIGS. 15 and 16, may allbe applied to the rest of the embodiments shown and described.

1. An ostomy appliance for receiving discharge from a human stoma andcomprising: attachment means for attaching the appliance to theperistomal skin surface of a user of the appliance, and an ostomy pouchassembly comprising: an inner pouch attached to said attachment meansand having a first aperture for receiving the stoma of said user, saidinner pouch being defined by a flexible body side or proximal innerpouch wall and a flexible distal inner pouch wall, and one or moreperipherally extending inner pouch sealing seams, an outer pouchenclosing said inner pouch, attached to said attachment means and havinga second aperture for receiving said stoma and being aligned with saidfirst aperture, said outer pouch being defined by a flexible body sideor proximal outer pouch wall and a flexible distal outer pouch wall, andone or more peripherally extending outer pouch sealing seams, said oneor more outer pouch sealing seams being manually peelable such that theattachment forces provided by said one or more peelable outer pouchsealing seams may be overcome by manually pulling said distal outerpouch wall in a direction transverse to said one or more peelable outerpouch sealing seams, said one or more outer pouch sealing seams peelablyattaching said distal outer pouch wall directly to said proximal outerpouch wall; wherein said distal inner pouch wall is peelably attacheddirectly to said distal outer pouch wall at said one or moreperipherally extending inner pouch sealing seams, and said proximalinner pouch wall is peelably attached directly to said proximal outerpouch wall at said one or more peripherally extending inner pouchsealing seams.
 2. An ostomy appliance according to claim 1, wherein saidinner pouch is attached to said attachment means by a peelable interiorsealing seam extending around said stoma receiving aperture in saidinner pouch.
 3. An ostomy appliance according to claim 2, wherein thematerial of said inner pouch walls is biodegradable.
 4. An ostomyappliance according to claim 2, wherein said interior inner pouchscaling scam comprises a peeling action initiation zone, where interiorinner pouch sealing seam comprises a peak-like extent tapering in thedirection opposite a predetermined peeling direction.
 5. An ostomyappliance according to claim 2, wherein said interior inner pouchsealing seam comprises a peeling action ending zone, where the interiorinner pouch sealing seam comprises a peak-like extent tapering in apredetermined peeling direction.
 6. An ostomy appliance according claim2, wherein said peeble interior sealing seam is constituted by a sheetof film or textile with a fifth stoma receiving aperture and havingadhesive on both opposed surface.
 7. An ostomy appliance according claim1, wherein said inner pouch walls are made of a plastic film laminatedto a web of tissue paper, said web facing outwards relative to theinterior of said inner pouch.
 8. An ostomy appliance according to claim7, wherein said tissue paper and said plastic film are biodegradable. 9.An ostomy appliance according to claim 7, wherein said outer pouchpeelable seam is made by applying heat and/or RF to the outer surface ofone or both of said outer pouch walls.
 10. An ostomy appliance accordingto claim 7, wherein a significant portion of the fibers of said paperhave a generally uniform orientation and said orientation is transversalto a line extending from the top to the bottom of said outer and innerpouches when a user to which said pouches have been applied around astoma is standing erect, said orientation being generally orthogonal tosaid line.
 11. An ostomy appliance according to claim 1, wherein saidinner pouch walls are impermeable to liquid and gas and permeable toodors, and said outer pouch walls are impermeable to liquid, gas andodors.
 12. An ostomy appliance according to claim 1, wherein said one ormore outer pouch peeling seams comprises a peeling action initiationzone, where said one or more outer pouch sealing seams comprises apeak-like extent tapering in the direction opposite a predeterminedpeeling direction.
 13. An ostomy appliance according to claim 1, whereinsaid one or more outer pouch peeling seams comprises a peeling actionending zone, where said one or more outer pouch scaling seams comprisesa peak-like extent tapering in a predetermined peeling direction.
 14. Anostomy appliance according to claim 1, wherein said proximal outer pouchwall is attached to said attachment means by a heat sealed sealing seam.15. An ostomy appliance according to claim 1, wherein said proximalouter pouch wall is attached to said attachment means by a peelablesealing seam.
 16. An ostomy appliance according to claim 1, wherein saidattachment means comprises a face plate assembly comprising a wafer ofskin friendly adhesive material having a third aperture for receivingsaid stoma aligned with said first and second apertures, and a firstcoupling ring surrounding said third aperture and attached to said waferand in engagement with a second coupling ring surrounding said first andsecond apertures and attached to said proximal outer pouch wall and/orto said proximal inner pouch wall.
 17. An ostomy appliance according toclaim 16, wherein said proximal outer pouch wall is attached to saidsecond coupling ring by means of a heat sealed sealing seam.
 18. Anostomy appliance according to claim 16, wherein said proximal innerpouch wall is attached to said second coupling ring by means of saidpeelable interior sealing seam.
 19. An ostomy appliance according toclaim 16, wherein an annular insert having a sixth aperture forreceiving said stoma is provided within said second coupling ring forpreventing said stomal discharge from soiling said second coupling ring.20. An ostomy appliance according to claim 16, wherein said proximalinner pouch wall is attached to said proximal outer pouch wall in aregion surrounding said first and second apertures by means of saidpeelable interior sealing seam.
 21. An ostomy appliance according toclaim 1, wherein said attachment means comprises a face plate assemblycomprising a wafer of skin friendly adhesive material having a fourthaperture for receiving said stoma aligned with said first and secondapertures, and a carrier sheet attached to the distal surface of saidwafer and attached to said proximal outer pouch wall and to saidproximal inner pouch wall.
 22. An ostomy appliance according to claim21, wherein said proximal outer pouch wall is attached to said carriersheet by means of a heat sealed sealing seam.
 23. An ostomy applianceaccording to claim 21, wherein said proximal inner pouch wall isattached to said carrier sheet by means of said interior peelablesealing seam.
 24. An ostomy appliance according to claim 21, whereinsaid proximal inner pouch wall is attached to said proximal outer pouchwall in a region surrounding said first and second apertures by means ofsaid peelable interior sealing seam.
 25. An ostomy appliance accordingto claim 1, wherein said attachment forces provided by said one or morepeelable outer pouch sealing seams are such that the pulling forcerequired for manually eliminating said attachment forces is betweenapproximately 0.5 Newton and approximately 6 Newton.
 26. An ostomyappliance according to claim 25, wherein said outer pouch peelablesealing seams are between 4 and 6 mm wide.
 27. An ostomy applianceaccording to claim 1, wherein at least a portion of the outer peripheraledges of said outer pouch walls and said inner pouch walls has beenformed by cutting through said portion of the outer peripheral edges inthe areas of said outer pouch peelable seams.
 28. An ostomy applianceaccording to claim 1, wherein a portion of said outer pouch walls extendbeyond said outer pouch peelable seams to form gripping tabs for peelingsaid walls apart gripping tabs for peeling said walls apart.